Socioeconomic Status and CD4 Count Among People with HIV Who Inject Drugs in St. Petersburg, Russia.

Lack of access to resources is a "fundamental cause" of poor HIV outcomes across the care cascade globally and may have the greatest impact on groups with co-existing marginalized identities. In a sample of people living with HIV (PWH) who inject drugs and were not on antiretroviral therapy (ART), we explored associations between access to resources and HIV severity. Fundamental Cause Theory (FCT) sees socioeconomic status/access to resources as a root cause of disease and emphasizes that individuals with limited resources have fewer means to mitigate health risks and implement protective behaviors, which ultimately generates disparities in health outcomes. Guided by the FCT, we hypothesized that resource depletion (primary aim) and lower income (secondary aim) were associated with increased HIV severity. Using baseline data from the Linking Infectious and Narcology Care (LINC-II) trial of ART-naive PWH who inject drugs in St. Petersburg, Russia (n = 225), we examined the association between "past year resource runout" (yes vs. no) and "low-income (< 300 USD a month)" and the outcome HIV severity (CD4 count, continuous). We fit two separate linear regression models adjusted for gender, age, time since HIV diagnosis, and prior ART use. Participants had a mean age of 37.5 years and were 60% male. Two thirds (66%) reported resource depletion, and 30% had income below 300 USD a month. Average CD4 count was 416 cells/mm3 (SD 285). No significant association was identified between either resource depletion or low-income and HIV severity (adjusted mean difference in CD4 count for resource depletion: - 4.16, 95% CI - 82.93, 74.62; adjusted mean difference in CD4 count for low-income: 68.13, 95% CI - 15.78, 152.04). Below-average income and running out of resources were common among PWH who inject drugs and are not on ART in St. Petersburg, Russia. Resource depletion and low-income were not significantly associated with HIV disease severity as captured by CD4 count. The nuanced relationship between socioeconomic status and HIV severity among people with HIV who inject drugs and not on ART merits further examination in a larger sample.

Provider-patient experiences and HIV care utilization among people living with HIV who inject drugs in St. Petersburg, Russia.

Providers' disrespect and abuse of patients is a recognized but understudied issue affecting quality of care and likely affecting healthcare utilization. Little research has examined this issue among people living with HIV (PWH) who inject drugs, despite high stigmatization of this population. No research has examined this issue in the context of Russia. This study assesses patients' reports of disrespect and abuse from providers as a barrier to healthcare and examines the association between these reports and HIV care outcomes.We conducted a cross-sectional analysis of the associations between disrespect/abuse from health providers as a barrier to care and the following HIV care outcomes: (i) anti-retroviral treatment (ART) uptake ever, (ii) past 6-month visit to HIV provider, and (iii) CD4 count. Participants (N = 221) were people living with HIV who injected drugs and were not on ART at enrollment.Two in five participants (42%) reported a history disrespect/abuse from a healthcare provider that they cited as a barrier to care. Those reporting this concern had lower odds of ever use of ART (adjusted odds ratio 0.46 [95% CI 0.22, 0.95]); we found no significant associations for the other HIV outcomes. We additionally found higher representation of women among those reporting prevalence of disrespect/abuse from provider as a barrier to care compared to those not reporting this barrier (58.1% versus 27.3%).Almost half of this sample of PWH who inject drugs report disrespect/abuse from a provider as a barrier to healthcare, and this is associated with lower odds of receipt of ART but not with other HIV outcomes studied. There is need for improved focus on quality of respectful and dignified care from providers for PWH who inject drugs, and such focus may improve ART uptake in Russia.

Hospitalization as an opportunity to engage underserved individuals in shared decision-making for lung cancer screening: results from two randomized pilot trials.

PURPOSE: Medicare requires tobacco dependence counseling and shared decision-making (SDM) for lung cancer screening (LCS) reimbursement. We hypothesized that initiating SDM during inpatient tobacco treatment visits would increase LCS among patients with barriers to proactively seeking outpatient preventive care. METHODS: We collected baseline assessments and performed two pilot randomized trials at our safety-net hospital. Pilot 1 tested feasibility, acceptability, and preliminary efficacy of a nurse practitioner initiating SDM for LCS during hospitalization (Inpatient SDM). We collected qualitative data on barriers encountered during Pilot 1. Pilot 2 added a community health worker (CHW) to address barriers to LCS completion (Inpatient SDM + CHW-navigation). For both studies, preliminary efficacy was an intention-to-treat analysis of LCS completion at 3 months between intervention and comparator (furnishing of LCS decision aid only) groups. RESULTS: Baseline assessments showed that patients preferred in-person LCS discussions versus self-reviewing materials; overall 20% had difficulty understanding written information. In Pilot 1, 4% (2/52) in Inpatient SDM versus 2% (1/48, comparator) completed LCS (p = 0.6), despite 89% (89/100) desiring LCS. Primary care providers noted that competing priorities and patient factors (e.g., social barriers to keeping appointments) prevented the intervention from working as intended. In Pilot 2, 50% (5/10) in Inpatient SDM + CHW-navigation versus 9% (1/11, comparator) completed LCS (p < 0.05). Many patients were ineligible due to recent diagnostic chest CT (Pilot 1: 255/659; Pilot 2: 239/527). CONCLUSIONS: Inpatient SDM + CHW-navigation shows promise to improve LCS rates among underserved patients who smoke, but feasibility is limited by recent diagnostic chest CT among inpatients. Implementing CHW-navigation in other clinical settings may facilitate LCS for underserved patients. TRAIL REGISTRATION: ClinicalTrials.gov Identifier: NCT03276806 (8 September 2017); NCT03793894 (4 January 2019).

Resilience and diabetes self-management among African-American men receiving primary care at an urban safety-net hospital: a cross-sectional survey.

BACKGROUND: Resilience is the ability to adapt to adverse life events. Studies that explore diabetes self-management interventions integrating resilience in African-Americans with diabetes include few African-American men, who have higher diabetes-related mortality and complication rates compared to African-American women. DESIGN: We conducted a cross-sectional study of African-American men with uncontrolled diabetes living in diabetes hotspots. We measured resilience levels using the General Self Efficacy Scale (GSES), adherence to diabetes self-management behaviors using the Diabetes Self-Management Questionnaire (DSMQ), and incarceration history by phone survey. We categorized participants as higher or lower resilience level and higher or lower adherence to diabetes self-management behaviors. Using multivariable logistic regression, we examined the relationship between resilience and adherence to diabetes self-management behaviors. Our model accounted for potential confounders, including age, incarceration history, and socioeconomic factors. RESULTS: Of 234 patients contacted by mail and phone, 94 (40.2%) completed the survey. Mean age was 60.6 years, 59.5% reported an annual household income of less than $20,000, and 29.8% reported a history of incarceration. The mean unadjusted GSES score was 25.0 (sd 5.2; range: 0-30, higher scores indicate greater resilience), and the mean DSMQ score was 7.34 (sd 1.78; range: 0-10, higher scores indicate greater adherence to diabetes self-management behaviors). In multivariable analyses, higher levels of resilience were associated with higher adherence to diabetes self-management behaviors (aOR = 9.68, 95% CI 3.01, 31.12). History of incarceration was negatively associated with higher adherence to diabetes self-management behaviors (aOR = 0.23, 95% CI 0.06, 0.81). CONCLUSIONS: Resilience and personal history of incarceration are associated with adherence to diabetes self-management behaviors among African-American men residing in diabetes hotspots. Future interventions should incorporate resilience training to improve diabetes self-management behaviors. At a societal level, social determinants of health that adversely affect African-American men, such as structural racism and mass incarceration, need to be eliminated.

Evaluation of an experiential clinical learning option during pandemic teaching suspensions.

BACKGROUND: As students' direct patient contact was suspended because of COVID-19-related restrictions, we revised our clinical addiction medicine curriculum for students to learn about the different multidisciplinary clinical models delivered at our hospital and in community settings. Our aim was to provide an overview of clinical modalities and familiarize learners with clinician and patient experiential perspectives. METHODS: We implemented a multi-pronged approach, offering an overview of clinical care programs through remote panels involving care providers at the clinics where students had previously been scheduled for in-person rotations. This included inpatient and office-based addiction services, addiction treatment program for adolescents and young adults, integrated addiction care and HIV primary care clinic, and opioid use urgent care clinic. Beyond having them join outpatient telehealth clinic visits, students also participated in an online panel involving patients in recovery to gain familiarity with their care perspectives; and joined a panel with recovery coaches to get further insights into patient challenges in clinical settings. Students further participated in remote opioid treatment trainings and observed clinical rounds of inpatient addiction consults and adolescent clinic team meetings. RESULTS: With this revised curriculum, students learned about the variety of clinical modalities at the height of our hospital's COVID-19 pandemic burden. The evaluation suggested that students appreciated the authenticity of accounts from patients and providers about their challenges and satisfaction related to clinical care. While in a remote learning setting, students overall wished for more personal interaction with patients and providers. They also noted a lack of group cohesion and connection that they felt would otherwise have been met in an in-person program. CONCLUSIONS: Remote learning allowed our program to connect trainees to the multidisciplinary field of addiction medicine despite the COVID-19 pandemic. In future program iterations, we will consider hybrid formats of in-person learning experiences with direct patient and faculty contact where possible, combined with online provider and patient panels possibly, in addition to virtual breakout formats to facilitate more personal student-patient and student-faculty interactions.

A Hepatitis C Treatment Program Based in a Safety-Net Hospital Patient-Centered Medical Home.

Hepatitis C virus (HCV) infection is a major public health problem. Urban safety-net hospitals are a prime location for HCV treatment delivery. Showing that physicians in primary care settings can deliver HCV infection care is important to expand treatment; models doing so in the era of newer oral HCV medications are needed. This article describes an innovative and successful HCV primary care treatment program in a patient-centered medical home based at an urban, safety-net hospital. The program is public health oriented in that a central team member is a public health social worker who performs population management and addresses underlying social determinants of health to facilitate engagement in HCV treatment. Other team members include general internists trained to treat HCV infections, a pharmacist, and a pharmacy technician. The program is funded with revenue generated by the 340b drug discount program, which allows providers to generate revenue when patients fill prescriptions at pharmacies in safety-net settings, as insurance reimbursements for medications exceed the cost at which safety-net providers purchase medications. During the course of 1 year, the program received 302 referrals. Of these approximately 23% have received treatment.

Using Photovoice and Asset Mapping to Inform a Community-Based Diabetes Intervention, Boston, Massachusetts, 2015.

INTRODUCTION: Diabetes self-management takes place within a complex social and environmental context.  This study's objective was to examine the perceived and actual presence of community assets that may aid in diabetes control. METHODS: We conducted one 6-hour photovoice session with 11 adults with poorly controlled diabetes in Boston, Massachusetts.  Participants were recruited from census tracts with high numbers of people with poorly controlled diabetes (diabetes "hot spots").  We coded the discussions and identified relevant themes.  We further explored themes related to the built environment through community asset mapping.  Through walking surveys, we evaluated 5 diabetes hot spots related to physical activity resources, walking environment, and availability of food choices in restaurants and food stores. RESULTS: Community themes from the photovoice session were access to healthy food, restaurants, and prepared foods; food assistance programs; exercise facilities; and church.  Asset mapping identified 114 community assets including 22 food stores, 22 restaurants, and 5 exercise facilities.  Each diabetes hot spot contained at least 1 food store with 5 to 9 varieties of fruits and vegetables.  Only 1 of the exercise facilities had signage regarding hours or services.  Memberships ranged from free to $9.95 per month.  Overall, these findings were inconsistent with participants' reports in the photovoice group. CONCLUSION: We identified a mismatch between perceptions of community assets and built environment and the objective reality of that environment. Incorporating photovoice and community asset mapping into a community-based diabetes intervention may bring awareness to underused neighborhood resources that can help people control their diabetes.

Comparative costs and potential affordability of a multifaceted intervention to improve treatment outcomes among people with HIV who inject drugs in Russia: economic evaluation of the LINC-II randomized controlled trial.

INTRODUCTION: The LINC-II randomized controlled trial in St. Petersburg, Russia for HIV-positive adults who inject drugs found that a multi-component intervention including initiation of antiretroviral therapy (ART) during admission to an addiction hospital, strengths-based case management and naltrexone significantly increased 12-month HIV viral suppression and ART retention. We conducted a comparative cost analysis to determine if the 12-month cost of the intervention is affordable within the current Russian health system. METHODS: We used LINC-II trial records and questionnaire responses to calculate the resources utilized by each participant in the study, including inpatient days, medications, laboratory tests, outpatient consultations, case manager interactions and opioid medication treatment. Quantities of resources utilized were multiplied by unit costs for each resource estimated from the service fee or price lists used by the study facilities for each specific service delivered. We report the average cost/study primary (viral suppression at 12 months) or secondary (retention in care at 12 months) outcome/participant in 2021 USD and compare costs between study arms. RESULTS: The trial enrolled 225 participants (111 intervention, 114 control) between September 2018 and December 2020. Viral suppression, non-suppression and missing suppression results were 28% and 14%, 49% and 37%, and 31% and 41% for the control and intervention arms, respectively. Retention results were 35% and 51% for the control and intervention arms, respectively. The average cost per study participant was $2714 in the control arm and $4342 in the intervention arm. The average cost per participant virally suppressed at 12 months was $3662 (control) and $6355 (intervention). The average cost per participant retained at 12 months was $4050 (control) and $5448 (intervention). For those retained, the cost difference between the arms was comprised of opioid treatment (35%), case management (31%), outpatient visits (18%) and additional days of ART (12%). CONCLUSIONS: The LINC-II intervention increased the cost of care for HIV-positive people who inject drugs in Russia significantly, but some components of the intervention, particularly earlier initiation of ART and case management, may be justifiable due to their success in reaching a challenging subgroup of the population in need. CLINICAL TRIAL NUMBER: NCT03290391.

Stigma and other correlates of sharing injection equipment among people with HIV in St. Petersburg, Russia.

Stigma that people with HIV who inject drugs experience negatively impacts HIV and substance use care, but stigma's association with sharing injection equipment is not known. This is a cross-sectional analysis of data from two studies of people with HIV reporting drug injection (N = 319) in St. Petersburg, Russia (September 2018-December 2020). We used logistic regression to examine associations between HIV stigma and substance use stigma scores (categorised into quartiles) and past 30-day equipment sharing, adjusting for demographic and clinical characteristics. Secondary analyses examined associations of arrest history and social support with sharing equipment. Almost half (48.6%) of participants reported sharing injection equipment. Among groups who did and did not share, mean HIV stigma (2.3 vs 2.2) and substance use stigma (32 vs 31) scores were similar. Adjusted analyses detected no significant associations between HIV stigma quartiles (global p-value = 0.85) or substance use stigma quartiles (global p-value = 0.51) and sharing equipment. Neither arrest history nor social support were significantly associated with sharing equipment. In this cohort, sharing injection equipment was common and did not vary based on stigma, arrest history, or social support. To reduce equipment sharing, investments in sterile injection equipment access in Russia should be prioritised over interventions to address stigma.

Evaluation of a student clinical research education program in addiction medicine.

OBJECTIVE: To evaluate an experiential student clinical addiction research program by analyzing its components, evaluation survey data, and scientific outputs. METHODS: In 1995, we established a summer research program supporting trainees to gain exposure to clinical addiction research careers. This curriculum employed a three-pronged approach that combined mentored research training, didactic education, and clinical observerships for medical students and other trainees to acquire experience with addiction medicine and research. Utilizing the Kirkpatrick model as program evaluation framework, we analyzed evaluation data from programmatic surveys (didactic seminar evaluations, overall program surveys) and conducted qualitative feedback exploration. RESULTS: Between 2007 and 2019, 56 trainees and 26 faculty mentors participated in the curriculum. To date, 25 students published 38 papers with their faculty mentor. Analysis of the past 12 years of program evaluation data demonstrated that students highly valued individually-mentored research experiences. They indicated that seminars familiarized them with the foundations of different clinical care models and career trajectories in addiction medicine. Clinical observerships provided students with patient contacts in various multidisciplinary addiction treatment settings. These experiences, perhaps most importantly hearing about patients' lived experiences, meaningfully informed various research and didactic activities. CONCLUSIONS: This summer student research program successfully introduced students to addiction medicine and research, manifested by high peer-reviewed publication productivity. While our program engaged and involved committed mentors and inspired mentees to pursue professional paths in addiction research, it did not specifically incorporate attention to equity and diversity into program planning and implementation. Going forward, the program will improve equity by increasing the recruitment of trainees from disadvantaged groups and engaging underrepresented faculty.KEY MESSAGESSummer programs can be effective in engaging medical students and trainees in research early in their trajectory and inspire them to incorporate research into their careers.Programs that integrate experiential addiction research learning, i.e. mentored research activities, didactic sessions, and clinical observerships, can provide trainees with a profound understanding of substance use disorder treatment and research.

Rapid access to antiretroviral therapy, receipt of naltrexone, and strengths-based case management versus standard of care for HIV viral load suppression in people with HIV who inject drugs in Russia (LINC-II): an open-label, randomised controlled trial.

BACKGROUND: Antiretroviral therapy (ART) coverage in Russia is low for people with HIV who inject drugs. HIV and addiction treatment in Russia are not well integrated. We aimed to evaluate an intervention to link people with HIV in addiction treatment to HIV care to achieve HIV viral load suppression. METHODS: LINC-II was a two-arm, open-label, randomised controlled trial at the City Addiction Hospital, Saint Petersburg, Russia. Eligible participants were aged 18 years or older, had a positive HIV status, were not currently on ART, were admitted to a narcology hospital, and had a current diagnosis of opioid use disorder. Participants were randomly assigned (1:1) to a multicomponent intervention (ie, rapid access to ART, naltrexone for opioid use disorder, and strengths-based case management) or standard of care. Blocked randomisation was stratified by history of ART use. The primary outcome was undetectable HIV viral load at 12 months, defined as less than 40 copies per mL. The trial was conducted and analysed according to the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, NCT03290391. FINDINGS: Between Sept 19, 2018, and Dec 25, 2020, 953 individuals were screened for eligibility, 225 of whom were randomly assigned to the intervention (n=111) or standard of care (n=114). 136 (60%) participants were male and 89 (40%) were female. Participants in the intervention group had higher odds of HIV viral load suppression at 12 months compared with participants in the standard-of-care group (52 [47%] vs 26 [23%]; adjusted odds ratio 3·0 [95% CI 1·4-6·4]; p=0·0039). 21 adverse events (18 in the intervention group and three in the standard-of-care group)and 14 deaths (four in the intervention group and ten in the standard-of-care group) were reported in the study. INTERPRETATION: Given the effectiveness of the LINC-II intervention, scaling up this model could be one strategy to advance the UNAIDS goal of ending the HIV epidemic. FUNDING: National Institute on Drug Abuse and Providence/Boston Center for AIDS Research.

Incarceration history, antiretroviral therapy, and stigma: A cross-sectional study of people with HIV who inject drugs in St. Petersburg, Russia.

BACKGROUND: The HIV epidemic is intertwined with substance use and incarceration in Russia. The relationships between incarceration history, HIV treatment history, and stigma experiences among people with HIV (PWH) who inject drugs in Russia have not been well described. METHODS: We conducted a cross-sectional study of a cohort of PWH with opioid use disorder who inject drugs (n=201) recruited at a narcology (substance use treatment) hospital in St. Petersburg, Russia from September 2018 to December 2020. The primary analysis evaluated the association between self-reported prior incarceration and prior antiretroviral therapy (ART) initiation using multivariable logistic regression to adjust for demographic, social, and clinical covariates. We used multivariable linear regression models to analyze associations between prior incarceration and two secondary outcomes: HIV stigma score (11-item abbreviated Berger scale) and substance use stigma score (21-item combination of Substance Abuse Self-Stigma Scale and Stigma-related Rejection Scale). RESULTS: Mean age was 37 (SD 5) years; 58.7% were male. Participants had been living with HIV for a mean of 13 (SD 6) years. Over two thirds (69.2%) of participants reported prior incarceration. One third (35.3%) of participants reported prior ART initiation. Prior incarceration was not significantly associated with prior ART initiation (AOR 1.76; 95% CI: 0.81, 3.83). Prior incarceration was associated with a lower HIV stigma score (adjusted mean difference in z-score: -0.50; 95%CI: -0.81, -0.19) but was not significantly associated with substance use stigma score (adjusted mean difference in z-score: -0.10; 95%CI: -0.42, 0.21). CONCLUSION: Prior incarceration was common, and rates of prior ART initiation were low even though most participants had been living with HIV for at least a decade. We did not find an association between prior incarceration and prior ART initiation, which suggests a need to explore whether opportunities to initiate ART during or after incarceration are missed. CLINICAL TRIAL NUMBER: NCT03290391.

Patient navigation among recently hospitalized smokers to promote tobacco treatment: Results from a randomized exploratory pilot study.

INTRODUCTION: Adding screening for health-related social needs to tobacco treatment interventions initiated during hospitalizations may improve intervention effectiveness among vulnerable populations. Our objective was to examine the effect the acceptability and feasibility of a intervention in which a patient navigator screens for and addresses social needs to increase receipt of smoking cessation medication among recently hospitalized smokers at a safety-net hospital. METHODS: In a two-group randomized exploratory pilot study, we assigned hospitalized smokers to either the Enhanced Traditional Control (ETC) group (list of smoking cessation resources) or ETC + Patient Navigation (up to 10 h of navigation over a 3-month period, in which a navigator screens for and addresses health-related social needs). We assessed socio-demographics, smoking-related variables, and process data. RESULTS: Of 171 individuals screened, 44 (26%) were enrolled. Participants (mean age = 54.9 years, 61.4% non-Hispanic black, 68.2% high school education or less) smoked a mean of 11.4 cigarettes/day. 20 participants received a prescription for a cessation medication, 42.9% in the ETC group and 47.8% in the ETC + Patient Navigation group. 11 participants (47.8%) in the ETC + Patient Navigation group received the minimum intervention dose (completion of the social needs screener and at least one counseling session). Barriers to navigation were participants' medical illness and difficulty connecting with participants. CONCLUSIONS: Although nearly half of hospitalized smokers receiving support from a patient navigator received a prescription for a smoking cessation medication, the percentage did not differ by study arm. Refinement of the protocol to coordinate with hospital-wide tobacco treatment and social needs screening initiatives is needed.

A financial incentive program to improve appointment attendance at a safety-net hospital-based primary care hepatitis C treatment program.

INTRODUCTION: Hepatitis C (HCV) infection is a significant health threat, with increasing incidence rates in the setting of the opioid crisis. Many patients miss appointments and cannot initiate treatment. We implemented financial incentives to improve appointment attendance in a primary care-based HCV treatment setting. METHODS: We conducted a systems-level financial incentives intervention at the Adult Primary Care HCV Treatment Program at Boston Medical Center which provides care to many patients with substance use disorders. From April 1 to June 30, 2017, we provided a $15 gift card to patients who attended appointments with an HCV treatment provider. We evaluated the effectiveness of the incentives by 1) conducting a monthly interrupted time series analysis to assess trends in attendance January 2016-September 2017; and 2) comparing the proportion of attended appointments during the intervention to a historical comparison group in the previous year, April 1 to June 30, 2016. RESULTS: 327 visits were scheduled over the study period; 198 during the intervention and 129 during the control period. Of patient visits in the intervention group, 72.7% were attended relative to 61.2% of comparison group visits (p = 0.03). Appointments in the intervention group were more likely to be attended (adjusted odds ratio 1.94, 95% confidence interval 1.16-3.24). Interrupted time series analysis showed that the intervention was associated with an average increase of 15.4 attended visits per 100 appointments scheduled, compared to the period prior to the intervention (p = 0.01). CONCLUSIONS: Implementation of a financial incentive program was associated with improved appointment attendance at a safety-net hospital-based primary care HCV treatment program. A randomized trial to establish efficacy and broader implementation potential is warranted.

Design of a randomized controlled trial to Link Infectious and Narcology Care (LINC-II) in St. Petersburg, Russia.

BACKGROUND: If Russia is to achieve the UNAIDS 90-90-90 HIV targets, better approaches to engage, effectively treat, and retain patients in care are needed. This paper describes the protocol of a randomized controlled trial (RCT) testing the effectiveness of LINC-II, a strength-based case management program for HIV-positive people who inject drugs (PWID) to increase rates of HIV viral suppression, ART initiation, and opioid abstinence. METHODS: This RCT will enroll and randomize 240 participants, recruited from a narcology (addiction care) hospital in St. Petersburg, Russia. Participants are randomized to the intervention or control arms. Those in the intervention arm receive: (1) strengths-based HIV case management supporting coordinated care; (2) rapid ART initiation; and (3) pharmacotherapy for opioid use disorder. We will evaluate the intervention's effectiveness compared to standard of care on the following outcomes: (1) undetectable HIV viral load at 12 months (primary); (2) initiation of ART within 28 days of randomization; (3) change in CD4 count from baseline to 12 months; (4) retention in HIV care (i.e., ≥ 1 visit to medical care in 2 consecutive 6 month periods); (5) undetectable HIV viral load at 6 months; and (6) past 30-day opioid abstinence (at 6 and at 12 months). DISCUSSION: This RCT will assess the LINC-II intervention in an urban Russian setting. If effective, it will offer a new approach for increasing the uptake of both HIV and opioid use disorder treatment and coordination of these modalities in standard Eastern European clinical settings. Trial registration This study was registered with ClinicalTrials.gov through the National Institutes of Health, NCT03290391. Registered 19 September 2017, https://clinicaltrials.gov/ct2/show/NCT03290391.

Budgetary impact analysis of a primary care-based hepatitis C treatment program: Effects of 340B Drug Pricing Program.

PURPOSE: Safety-net health systems, which serve a disproportionate share of patients at high risk for hepatitis C virus (HCV) infection, may use revenue generated by the federal drug discount pricing program, known as 340B, to support multidisciplinary care. Budgetary impacts of repealing the drug-pricing program are unknown. Our objective was to conduct a budgetary impact analysis of a multidisciplinary primary care-based HCV treatment program, with and without 340B support. METHODS: We conducted a budgetary impact analysis from the perspective of a large safety-net medical center in Boston, Massachusetts. Participants included 302 HCV-infected patients (mean age 45, 75% male, 53% white, 77% Medicaid) referred to the primary care-based HCV treatment program from 2015-2016. Main measures included costs and revenues associated with the treatment program. Our main outcomes were net cost with and without 340B Drug Pricing support. RESULTS: Total program costs were $942,770, while revenues totaled $1.2 million. With the 340B Drug Pricing Program the hospital received a net revenue of $930 per patient referred to the HCV treatment program. In the absence of the 340B program, the hospital would lose $370 per patient referred. Ninety-seven percent (68/70) of patients who initiated treatment in the program achieved a sustained virologic response (SVR) at a net cost of $4,150 each, among this patient subset. CONCLUSIONS: The 340B Drug Pricing Program enabled a safety-net hospital to deliver effective primary care-based HCV treatment using a multidisciplinary care team. Efforts to sustain the 340B program could enable dissemination of similar HCV treatment models elsewhere.

Process evaluation of counseling delivered by a patient navigator in an efficacious smoking cessation intervention among low-income primary care patients.

INTRODUCTION: This exploratory study examined the relationship between receipt of counseling by a patient navigator and socio-demographic characteristics of primary care patients enrolled in a smoking cessation trial. METHODS: We grouped intervention participants (n = 177) into two categories: 1) no or some contact with the navigator or 2) minimum counseling intervention dose or higher delivered. RESULTS: In logistic regression analyses, controlling for patient race/ethnicity, education, age, gender, household annual income, stress/chaos/hassles composite score, heavy smoking, and substance use, non-Hispanic white participants had lower odds (aOR 0.30; 95% CI 0.13-0.70, p < 0.01) of receiving the minimum intervention dose or higher compared to all other race/ethnicity categories. There was also effect modification such that patients aged 50 or younger who were non-Hispanic white were less likely (aOR 0.09, 95% CI: 0.02-0.54, p < 0.01) to receive the minimum intervention dose compared to older patients from all other race/ethnicity groups. CONCLUSIONS: Future research should explore issues such as acceptability of the intervention to white and younger age participants, and the potential impact of co-occurring substance use disorders on intervention uptake.

Effect of Patient Navigation and Financial Incentives on Smoking Cessation Among Primary Care Patients at an Urban Safety-Net Hospital: A Randomized Clinical Trial.

Importance: While the proportion of adults who smoke cigarettes has declined substantially in the past decade, socioeconomic disparities in cigarette smoking remain. Few interventions have targeted low socioeconomic status (SES) and minority smokers in primary care settings. Objective: To evaluate a multicomponent intervention to promote smoking cessation among low-SES and minority smokers. Design, Setting, and Participants: For this prospective, unblinded, randomized clinical trial conducted between May 1, 2015, and September 4, 2017, adults 18 years and older who spoke English, smoked 10 or more cigarettes per day in the past week, were contemplating or preparing to quit smoking, and had a primary care clinician were recruited from general internal medicine and family medicine practices at 1 large safety-net hospital in Boston, Massachusetts. Interventions: Patients were randomized to a control group that received an enhancement of usual care (n = 175 participants) or to an intervention group that received up to 4 hours of patient navigation delivered over 6 months in addition to usual care, as well as financial incentives for biochemically confirmed smoking cessation at 6 and 12 months following enrollment (n = 177 participants). Main Outcomes and Measures: The primary outcome determined a priori was biochemically confirmed smoking cessation at 12 months. Results: Among 352 patients who were randomized (mean [SD] age, 50.0 [11.0] years; 191 women [54.3%]; 197 participants who identified as non-Hispanic black [56.0%]; 40 participants who identified as Hispanic of any race [11.4%]), all were included in the intention-to-treat analysis. At 12 months following enrollment, 21 participants [11.9%] in the navigation and incentives group, compared with 4 participants [2.3%] in the control group, had quit smoking (odds ratio, 5.8; 95% CI, 1.9-17.1; number needed to treat, 10.4; P < .001). In prespecified subgroup analyses, the intervention was particularly beneficial for older participants (19 [19.8%] vs 1 [1.0%]; P < .001), women (17 [16.8%] vs 2 [2.2%]; P < .001), participants with household yearly income of $20 000 or less (15 [15.5%] vs 3 [3.1%]; P = .003), and nonwhite participants (21 [15.2%] vs 4 [3.0%]; P < .001). Conclusions and Relevance: In this study of adult daily smokers at 1 large urban safety-net hospital, patient navigation and financial incentives for smoking cessation significantly increased the rates of smoking cessation. Trial Registration: clinicaltrials.gov Identifier: NCT02351609.

Patient navigation and financial incentives to promote smoking cessation in an underserved primary care population: A randomized controlled trial protocol.

Despite the high risk of tobacco-related morbidity and mortality among low-income persons, few studies have connected low-income smokers to evidence-based treatments. We will examine a smoking cessation intervention integrated into primary care. To begin, we completed qualitative formative research to refine an intervention utilizing the services of a patient navigator trained to promote smoking cessation. Next, we will conduct a randomized controlled trial combining two interventions: patient navigation and financial incentives. The goal of the intervention is to promote smoking cessation among patients who receive primary care in a large urban safety-net hospital. Our intervention will encourage patients to utilize existing smoking cessation resources (e.g., quit lines, smoking cessation groups, discussing smoking cessation with their primary care providers). To test our intervention, we will conduct a randomized controlled trial, randomizing 352 patients to the intervention condition (patient navigation and financial incentives) or an enhanced traditional care control condition. We will perform follow-up at 6, 12, and 18 months following the start of the intervention. Evaluation of the intervention will target several implementation variables: reach (participation rate and representativeness), effectiveness (smoking cessation at 12 months [primary outcome]), unintended consequences (e.g., purchase of illicit substances with incentive money), adoption (use of intervention across primary care suites), implementation (delivery of intervention), and maintenance (smoking cessation after conclusion of intervention). Improving the implementation of smoking cessation interventions in primary care settings serving large underserved populations could have substantial public health impact, reducing cancer-related morbidity/mortality and associated health disparities.